CRS Certificate

Entering the Indian healthcare market involves more than having a good product. If a business plans to manufacture, import, distribute, or market medicines, medical devices, or cosmetics, it must first understand the applicable regulatory requirements. This is where the Central Drugs Standard Control Organization (CDSCO) becomes important. CDSCO is India's central regulatory authority for drugs and several other healthcare-related products. It works under the Ministry of Health and Family Welfare and administers various laws and rules, including the Drugs and Cosmetics Act, 1940, Drugs Rules, 1945, Medical Devices Rules, 2017, New Drugs and Clinical Trials Rules, 2019, and Cosmetics Rules, 2020. One important point is that there is no single licence that covers every product or business activity. The approval required depends on the product, its intended use, the activity being carried out, and whether the product is manufactured in India or imported. What Is a CDSCO Licence? A CDS...

Under the Cosmetics Rules, 2020 (notified by the Ministry of Health and Family Welfare under the Drugs and Cosmetics Act, 1940), any cosmetic product imported into or manufactured in India must obtain regulatory approval from the Central Drugs Standard Control Organization ( CDSCO ) prior to commercial distribution. Imported cosmetics require a Registration Certificate in Form COS-2 (applied via Form COS-1 ), while domestic manufacturing requires a license in Form COS-9 (applied via Form COS-8 ) issued by the respective State Licensing Authority (SLA) or Central Authority based on product categorization. Quick Regulatory Reference Question Official Requirement / Provision Primary Regulator Central Drugs Standard Control Organization (CDSCO) & State Licensing Authorities (SLA) Governing Regulation Cosmetics Rules, 2020 (enforced under Drugs and Cosmetics Act, 1940) Import Application Form Form COS-1 (Yields Registration Certificate in Form COS-2 ) Manufacturing Application Form ...